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IRCT20130523013442N33 IRCT 2023-09-17 Shahid Beheshti University of Medical Sciences Comparison of ultrasound guided injection of botulinum toxin at the origin of plantar fasciitis with injection of botulinum toxin by Babcock method in the treatment of plantar fasciitis Comparison of ultrasound guided injection of botulinum toxin at the origin of plantar fasciitis with injection of botulinum toxin by Babcock method in the treatment of plantar fasciitis 2023-09-23 anticipated 60 Complete https://irct.ir/trial/72584 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this clinical trial study, 60 patients diagnosed with plantar fasciitis will be randomly enrolled. Block randomization method will be used for random allocation of people in the studied groups. In this method, blocks of 6 will be used with a ratio of 1:1. Random Allocation software will be used to generate random sequences. For concealment, random allocation concealment method will be used, which is marked with the letters A (group receiving botulinum toxin in the origin of plantar fasciitis) and B (group receiving botulinum toxin by Babcock method) and recorded on cards. These cards will be placed in the sealed envelopes in order. In order to maintain the created sequence, numbering will be done on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then based on The order of entry of the eligible participants, the envelopes will be opened and the assigned group of that participant will be known, Blinding description: The study is single blind because it is not possible to blind patients and the clinical caregiver responsible for drug injection due to the difference in botulinum toxin injection location in the two groups. The injections are performed by a physical medicine specialist. The researcher and the person conducting the follow up and data analysts and outcome assessors who are blinded and unaware of the intervention performed on each group of patients And only the final data in the form of the first and second groups and random numbers assigned to each patient will be available. 3 plantar fasciitis. Intervention 1: Intervention group: included 30 patients who are treated with 150 unit botulinum toxin injection (Masport, Masson Darou) at the origin of the plantar fascia with 1 cc of 2% lidocaine. Intervention 2: Intervention group: Including 30 patients who are treated with 150 units botulinum toxin (Masport, Masson Darou) by Babcock method (90 units at the junction of the plantar fascia with the calcaneus and 60 units in the arch of the foot and at a point between the front of the heel and the middle of the foot's arch) with one cc of 2% lidocaine. Yes - There is a plan to make this available What will be shared: All the data of people participating in this study can be shared after deidentifying people When: The access period starts one year after the results are published. To whom: Data of this study will be available to researchers working in academic and scientific institutions. Conditions: If the goal of the researchers is to conduct a systematic review and meta-analysis on the data, the non-identifiable data of the patients will be provided to the researchers. Where to obtain: By sending an email to alin7093@gmail.com How to obtain: The application should contain information about the applicant, his/her affiliation, phone number, e-mail and the reason for his/her request. If these items are presented and the information related to the applicant's plan is registered and confirmed in the PROSPERO system, the information will be provided to the applicant. Comments:
public Ali Nazari Nodoushan
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 alin7093@gmail.com Shahid Beheshti University of Medical Sciences scientific Seyed Ahmad Raeissadat
Shahid Modarres Hospital, Kaj square, Saadat abad
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2207 4087 a_raeissadat@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) People aged 30 to 60 years who have been diagnosed with unilateral plantaris fasciitis based on history and clinical examination. After 3 months from the onset of symptoms and the use of conservative treatments, including rest, anti-inflammatory drugs, physical modalities and exercise therapy, the patient's symptoms have not improved. 30 years 60 years Both History of previous surgery for plantaris fasciitis. History of injection for treatment of plantaris fasciitis in the last 3 months. Bilateral plantaris fasciitis Presence of systemic inflammatory diseases such as rheumatoid arthritis and seronegative arthritis. History of vascular insufficiency and neuropathic heel pain Existence of concomitant diseases in the lower limbs, such as a history of tarsal tunnel syndrome symptoms and positive tinel sign. Presence of effusion in the ankle, which suggests an intra-articular disease Old fracture of calcaneal bone. Presence of retrocalcaneal bursitis, Achilles tendinopathy and ankle osteoarthritis Any ankle or foot deformity, including flat foot and pes cavus. Uncontrolled diabetes BMI more than 33 Radicular low back pain Presence of local infection or trauma near the injection site Use of anticoagulants Presence of diseases that involve the neuromuscular junction, such as myasthenia gravis and Eaton Lambert Known allergy and sensitivity to botulinum toxin or corticosteroids Presence of cyst or bone mass in the area of ​​the heel Pregnancy or breastfeeding M72.2 Plantar fascial fibromatosis Treatment - Drugs Treatment - Drugs Intervention group: included 30 patients who are treated with 150 unit botulinum toxin injection (Masport, Masson Darou) at the origin of the plantar fascia with 1 cc of 2% lidocaine. Intervention group: Including 30 patients who are treated with 150 units botulinum toxin (Masport, Masson Darou) by Babcock method (90 units at the junction of the plantar fascia with the calcaneus and 60 units in the arch of the foot and at a point between the front of the heel and the middle of the foot's arch) with one cc of 2% lidocaine.. Evaluation of the patient's heel pain. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Visual analogue scale (VAS). Assessment of plantar fascia thickness. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Measuring the thickness of the plantar fascia with ultrasonography. Pain pressure threshold. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Algometer. Assessment of the patient's performance in daily tasks. Timepoint: At the beginning of the study (before intervention) and 6 weeks and 24 weeks after the intervention. Method of measurement: Using the FFI-R questionnaire. Shahid Beheshti University of Medical Sciences Approved 2023-06-11 Research Ethics Committees of Shahid Beheshti University of Medical Sciences Shahid Beheshti University of Medical sciences, Shahid Arabi Street, Yaman Street, Shahid Chamran Highway, Velenjak, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)